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The Diabetes Prevention Program Outcomes Study : Our Contributions Carry On Long-term Follow-up to A Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High Risk The DPP/DPPOS Research Group. Diabetes Prevention Program Outcomes Study Clinics. Sponsors.

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Diabetes Prevention Program Outcomes Study Clinics

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The Diabetes Prevention ProgramOutcomes Study:Our Contributions Carry OnLong-term Follow-up to A Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High RiskThe DPP/DPPOS Research Group

Diabetes Prevention Program Outcomes Study Clinics




























  • National Institute of Diabetes & Digestive & Kidney Diseases

  • Other NIH Institutes, Offices

    • National Center on Minority Health and Health Disparities

    • National Institute of Child Health and Human Development

    • National Institute on Aging

    • National Center for Research Resources, GCRC Program

    • Office of Research on Women’s Health

    • National Eye Institute

    • National Heart Lung and Blood Institute

  • Other Federal Agencies

  • Indian Health Service

  • Centers for Disease Control and Prevention


  • American Diabetes Association

  • Industry grant support

  • Bristol-Myers Squibb

  • Additional Support

  • LifeScan, Inc

  • Lipha (Merck-Sante)

Study Timeline

DPP Primary Goal

  • To prevent or delay the development of type 2 diabetes in persons with impaired glucose tolerance (IGT)

DPP Study Treatment Groups

Screen (158,177 people)

Randomize (3,819 people)

Standard lifestyle teaching



(1079 people)


(1082 people)


(1073 people)


585 people

Until 6/98

DPP Incidence of Diabetes

Placebo (n=1082)

Metformin (n=1073, p<0.001 vs. Placebo)

Lifestyle (n=1079, p<0.001 vs. Metformin,

p<0.001 vs. Placebo)

Risk reduction

31% by metformin

58% by lifestyle

Keys to DPP Lifestyle Success

Weight loss was the key to diabetes prevention

Reduction of total calories, especially fat calories

Achieving 150 minutes of activity each week

Troglitazone Participants

  • There were fewer Troglitazone participants in DPP (n=585) than in the other groups (n~1000) since recruitment was stopped early

  • Treatment with Troglitazone only lasted for an average of 9 months and therefore the long term effects of Troglitazone on diabetes prevention are not known

  • During the brief period of Troglitazone treatment, development of diabetes was decreased by ~70% compared with Placebo

Bridge Period from DPP to DPPOS

Summer 2001 - Fall 2002

All participants continued their DPP treatments

Metformin participants completed medicine wash-out

January - June 2002

All DPP participants were offered a 16-session Group Lifestyle Balance Program

September 2002

Diabetes Prevention Program Outcomes Study begins

Who Joined DPPOS?

3251 DPP participants joined DPPOS

88% of the original DPP participants

Who Joined DPPOS at <insert clinic name>

  • <x> DPP participants joined DPPOS

  • <x>% of the original DPP participants


Diabetes delay or prevention

Prevention of diabetes complications such as kidney, eye and nerve problems, and heart disease

DPPOS Treatments

Original Placebo group

HELP classes four times a year

Original Metformin group

Metformin 850 mg twice daily

HELP classes four times a year

Original Lifestyle group

HELP classes four times a year

Boost lifestyle classes twice a year

Weight Change Over Time

DPPOS Incidence of Diabetes

DPPOS Incidence of Diabetes

DPP vs. DPPOS Diabetes Rates

Diabetes Development in DPPOS

Original Lifestyle participants continue to develop diabetes at the lower rate they developed diabetes during DPP.

Original Placebo and Metformin participants have lowered their rate of diabetes development to a similar rate as the Lifestyle group.

DPPOS Diabetes Risk Reduction

Delay in diabetes onset after 10 years follow-up:

4 years for Lifestyle

2 years for Metformin

The lower rate of diabetes development for lifestyle and metformin during DPP means:

Original Lifestyle participants have a 34% lower risk of diabetes compared to Placebo

Original Metformin participants have a 19% lower risk of diabetes compared to Placebo

Diabetes Frequency After 10 years

52% of Placebo participants have diabetes

47% of Metformin participants have diabetes

42% of Lifestyle participants have diabetes

Use of Anti-diabetic Medicines

Heart Disease Risk

All treatment groups have decreased blood pressure, cholesterol and triglycerides.

Lifestyle participants had the same or lower blood pressure and lipid levels over time than other participants with less use of medicines.

DPP/DPPOS Publications

Diabetes Prevention Program

Public Website


Here’s what to expect next in DPPOS

  • A mid-year and annual visit each year

  • Four HELP classes each year

  • A set of retinal (eye) photos in 2012

Additional DPPOS Treatments

  • Two BOOST campaigns each year for original Lifestyle participants.

  • Metformin participants are asked to continue to take study metformin.

  • DPP troglitazone participants will no longer have clinic visits for outcomes testing.

New Outcomes Measures

  • Cognitive (Memory) Testing

  • Physical Function Testing

Individual Results Summary

  • Over the next six months, you will receive a summary of your DPP and DPPOS testing

  • DPPOS staff will review this information with you and answer your questions

Your Health Care

  • Research is not a substitute for health care.

  • See your Primary Care Provider regularly to make personal decisions about your health care.

  • If you have diabetes, continue your regular eye exams, foot exams, etc.

Thank You for Your Contributions to Diabetes Research and Prevention

Your Contributions Carry On!

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